Soft tissue repair prosthesis and expandable device

ABSTRACT

A hernia repair device is provided which may include a soft tissue repair prosthesis and an expandable device configured to be removably connected with the soft tissue repair prosthesis. Attachment components may be used to removably connect the soft tissue repair prosthesis with the expandable device. The hernia repair device may be manipulated into a reduced configuration for insertion into the body. When expanded, the expandable device may be configured to position the soft tissue repair prosthesis adjacent a hernia defect. The expandable device and/or the attachment components may be shaped and/or configured to minimize the maximum dimension of the hernia repair device in its reduced configuration.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/877,835, now U.S. Pat. No. 9,808,331, which is a national stagefiling under 35 U.S.C. § 371 of International Application No.PCT/US2011/049732, filed on Aug. 30, 2011, entitled “SOFT TISSUE REPAIRPROSTHESIS AND EXPANDABLE DEVICE,” which claims the benefit of U.S.provisional application No. 61/389,792, filed on Oct. 5, 2010, entitled“SOFT TISSUE REPAIR PROSTHESIS AND EXPANDABLE DEVICE,” each of which areincorporated by reference herein in their entireties.

FIELD OF INVENTION

The present invention is directed to a soft tissue repair prosthesis, anexpandable device, and to attachment components for removably securingthe prosthesis with the expandable device.

BACKGROUND OF INVENTION

One technique for repairing a soft tissue defect, such as an abdominalwall hernia, involves inserting a soft tissue repair prosthesis, such asa mesh patch or plug, into an intra-abdominal space, positioning theprosthesis relative to the wall defect, and then, if desired, securingthe prosthesis with tacks, sutures, and/or adhesives.

To deliver the prosthesis intra-abdominally, the prosthesis may berolled up, folded or otherwise collapsed into a reduced configurationand then inserted through a small incision or a trocar and into theintra-abdominal space. The prosthesis is then unfurled and positionedrelative to the defect.

SUMMARY OF INVENTION

In one illustrative embodiment, a hernia repair device is provided whichincludes an expandable device configured to be removably connected witha soft tissue repair prosthesis, the expandable device having a firstaxis and a second axis, the first axis being substantially perpendicularto the second axis, and where the second axis defines a maximum width ofthe expandable device. The expandable device is configured to bemanipulated about the first axis into a reduced configuration forinsertion into a body. The hernia repair device further includes aplurality of attachment components associated with the expandable deviceto removably connect the prosthesis with the expandable device and theplurality of attachment components are offset from the second axis.

In another illustrative embodiment, a hernia repair device is providedwhich includes an expandable device configured to be removably connectedwith a soft tissue repair prosthesis, the expandable device having afirst axis and a second axis, the first axis being substantiallyperpendicular to the second axis, and the first axis intersecting thesecond axis at approximately the center of the expandable device. Theexpandable device is configured to be manipulated about the first axisinto a reduced configuration for insertion into a body. The expandabledevice includes an expandable forward portion spaced apart from anexpandable rear portion by a single intermediate portion which connectsthe forward portion to the rear portion. The forward portion and therear portion each include sections that extend outwardly from the firstaxis. A maximum dimension of the intermediate portion in the reducedconfiguration along a plane defined by the second axis is less than amaximum dimension of the expandable device at either the forward portionand the rear portion in the reduced configuration defined along a planesubstantially parallel to the second axis.

In yet another illustrative embodiment, a hernia repair device isprovided which includes an expandable device configured to be removablyconnected with a soft tissue repair prosthesis, the expandable devicehaving a first axis, where the expandable device is configured to bemanipulated about the first axis into a reduced configuration forinsertion into a body. The hernia repair device further includes aplurality of attachment components coupled to the expandable device toremovably connect the prosthesis with the expandable device. At leastone of the plurality of attachment components has a maximum dimensionwhich defines a longitudinal axis of the attachment component, and tominimize the size of the hernia repair device in its reducedconfiguration, the at least one of the plurality of attachmentcomponents is arranged on the expandable device such that itslongitudinal axis is substantially parallel to the first axis.

In yet a further illustrative embodiment, a hernia repair device isprovided which includes an expandable device configured to be removablyconnected with a soft tissue repair prosthesis and a plurality ofattachment components coupled to the expandable device to removablyconnect the prosthesis with the expandable device. The plurality ofattachment components are positioned to extend entirely within theperimeter of the expandable device.

In another illustrative embodiment, a hernia repair device is providedwhich includes a soft tissue repair prosthesis, and an expandable deviceremovably connected with the soft tissue repair prosthesis, theexpandable device having a first axis and a second axis, the first axisbeing substantially perpendicular to the second axis, and where thesecond axis defines a maximum width of the expandable device. Theexpandable device is configured to be manipulated about the first axisinto a reduced configuration for insertion into a body. The soft tissuerepair prosthesis has a maximum width defined in a directionsubstantially parallel to the second axis, and to minimize the size ofthe hernia repair device in its reduced configuration, the maximum widthof the expandable device is spaced apart from the maximum width of thesoft tissue repair prosthesis.

In yet a further illustrative embodiment, a hernia repair device isprovided which includes an inflatable device configured to be removablyconnected with a soft tissue repair prosthesis, the inflatable devicehaving a first axis where, when deflated, the inflatable device isconfigured to be manipulated about the first axis into a reducedconfiguration for insertion into a body. The inflatable device includesa plurality of reliefs spaced around the perimeter of the inflatabledevice configured to minimize bending of the inflatable device wheninflated.

In another illustrative embodiment, a method of assembling a herniarepair device is provided. The method includes the acts of arranging asoft tissue repair prosthesis on an expandable device with at least oneattachment component, where the prosthesis, expandable device andattachment component form a hernia repair device. The method furtherincludes manipulating the hernia repair device about a first axis into areduced configuration, where the soft tissue repair prosthesis isarranged on the expansion device such that a maximum dimension of thehernia repair device in the reduced configuration is minimized.

Various embodiments of the present invention provide certain advantages.Not all embodiments of the invention share the same advantages and thosethat do may not share them under all circumstances.

Further features and advantages of the present invention, as well as thestructure of various embodiments that incorporate aspects of theinvention are described in detail below with reference to theaccompanying drawings.

BRIEF DESCRIPTION OF DRAWINGS

The foregoing and other objects and advantages of the invention will beappreciated more fully from the following drawings, wherein likereference characters designate like features, in which:

FIG. 1A is a top view of an expandable device and soft tissue repairprosthesis according to one embodiment of the present invention;

FIGS. 1B, 1C and 1D are perspective views illustrating a hernia repairdevice being manipulated into a reduced configuration;

FIG. 2 illustrates an attachment component according to one embodimentof the present invention;

FIG. 2A illustrates the attachment component shown in FIG. 2 coupled toa soft tissue repair prosthesis;

FIG. 3-7 illustrate attachment components according to variousembodiments of the present invention; and

FIGS. 8-28 illustrate expandable devices according to variousembodiments of the present invention.

DETAILED DESCRIPTION

Aspects of the present invention are directed to a soft tissue repairprosthesis, such as a patch, plug, or patch and plug combination, foraugmenting, reconstructing or otherwise repairing a muscle or tissuewall, such as a chest wall or abdominal wall, and that has particularapplication for repairing a hernia defect to reconstruct the chest wall.

An expandable device may be provided for delivering, locating, orotherwise positioning the soft tissue repair prosthesis at the surgicalsite. The soft tissue repair prosthesis may be carried by or otherwiseconnected with the expandable device, such that manipulation of theexpandable device will effect the shape and/or position of the softtissue repair prosthesis. The expandable device may have a reducedconfiguration suitable for introduction to the surgical site and anexpanded configuration for deploying, locating, or otherwise positioningthe soft tissue repair prosthesis. Expansion of the expandable device,when connected with the soft tissue repair prosthesis, may cause thesoft tissue repair prosthesis to transform from a reduced deliveryprofile to an enlarged configuration suitable for the desired procedure,such as extending over, under, or filling a hernia defect. The term“hernia repair device” is used throughout the application and may beused to reference the expandable device, the soft tissue repairprosthesis, and/or the combination of the expandable device and softtissue repair prosthesis, as the invention is not limited in thisrespect.

As set forth below, the expandable device may be in the form of aballoon or other inflatable bladder, or other construction suitable fordelivery in a reduced configuration and expansion to a larger size. Thesoft tissue repair prosthesis may be mounted to, or otherwise connectedwith, the expandable device, and then the combined components may bereduced in size, such as by rolling, folding, collapsing, or otherwisemanipulating, and then inserted through a trocar or small incision intothe abdominal cavity or other surgical site. Expansion of the expandabledevice, such as by inflation where the expandable device is in the formof a balloon, will in turn cause the soft tissue repair prosthesis tomove into an expanded configuration suitable for the intended procedure.For example, where the soft tissue repair prosthesis is a mesh sheet andhas been rolled up with an associated balloon, inflation of the balloonwill cause the mesh sheet to unroll or otherwise expand into an enlargedconfiguration which can then be positioned relative to the defect.

Aspects of the present invention are directed to arrangements forconnecting an expandable device with a soft tissue repair prosthesis. Inone embodiment, the expandable device and soft tissue repair prosthesisare detachably connected. For example, and without limitation, one ormore attachment components may releasably connect the expandable deviceand soft tissue repair prosthesis. The attachment components may looselyconnect the prosthesis and the expandable device together in the reducedprofile. As set forth in greater detail below, the attachment componentsmay be configured and arranged to minimize the size of the hernia repairdevice in its reduced configuration.

Other aspects of the present invention are directed to variousconfigurations for the expandable device to minimize the size of thehernia repair device when in its reduced configuration.

Turning to FIG. 1A, one embodiment of a hernia repair device isillustrated. The hernia repair device includes an expandable device 100that is configured to be removably connected with a soft tissue repairprosthesis 200. A plurality of attachment components 300 a, 300 b, 300c, 300 d are provided to removably connect the prosthesis 200 with theexpandable device 100. In this particular embodiment, the attachmentcomponents 300 a-d are configured as substantially helical shaped coilsthat may be oriented to extend into/out of the page. As discussed below,in other embodiments, other types of attachment components are alsocontemplated as the invention is not so limited.

Applicant recognized the importance of minimizing the size of the herniarepair device when in its reduced configuration for insertion into abody. The hernia repair device is typically inserted through a smallincision or a trocar and into the intra-abdominal space. It may bedesirable to minimize the size of the incision or trocar. For example,in one particular embodiment, it may be desirable to use a trocar thatis 12 mm or less, which would require that the outer diameter, or othermaximum dimension, of the hernia repair device in its reducedconfiguration is 12 mm or less. In another embodiment, it may bedesirable to use a trocar that is 20 mm or less, which would requirethat the outer diameter, or other maximum dimension, of the herniarepair device in its reduced configuration is 20 mm or less. It shouldbe appreciated that when the hernia repair device is rolled into acylindrical configuration, it may have a diameter, but that inembodiments where the hernia repair device is folded or otherwisemanipulated into its reduced configuration, the device may have anon-circular cross-section and will still have a maximum dimension. Theterm “maximum dimension” is used throughout the application and may beused to reference this outer dimension of the hernia repair device, orcomponents of the hernia repair device, when in the reducedconfiguration.

As set forth below, Applicant recognized that the particular placementof the attachment components relative to the expandable device and/orprosthesis may be optimized to minimize the maximum dimension of thehernia repair device in its reduced configuration. Applicant recognizedthat the attachment components may be thicker than the prosthesis and/orthe expandable device, and thus, strategic placement of the attachmentcomponents may help to minimize the maximum dimension of the herniarepair device when in its reduced configuration. This may help tominimize the size of the incision or trocar needed to delivery thehernia repair device into the body. For example, as discussed in greaterdetail below, in one embodiment, the attachment components may be offsetfrom the maximum width portion of the expandable device and/orprosthesis. As set forth below, in another embodiment, the attachmentcomponents may be positioned relative to the expandable device such thattwo attachment components are not stacked onto each other when thehernia repair device is manipulated into its reduced configuration.

As illustrated in FIG. 1A, the expandable device 100 has a first axis110 and the expandable device 100 is configured to be furled, orotherwise manipulated, about the first axis 110 into a reducedconfiguration for insertion into a body. Thus, the first axis 110 mayalso be referred to as the furling axis, rolling axis, or manipulationaxis. The expandable device also has a second axis 120 which issubstantially perpendicular to the first axis. As shown, the second axis120 defines a maximum width of the expandable device 100 in a planesubstantially perpendicular to the first axis 110. In this particularillustrative embodiment, the first axis 110 intersects the second axis120 at approximately the center of the expandable device. However, itshould be appreciated that in another embodiment where the expandabledevice is shaped differently, the first axis 110 may intersect thesecond axis 120 at a location spaced apart from the center of theexpandable device.

As illustrated in FIG. 1A, a plurality of attachment components 300 a,300 b, 300 c, 300 d are associated with the expandable device 100 toremovably connect the prosthesis 200 with the expandable device 100. Inthis particular embodiment, the attachment components 300 a-d aremechanical fasteners coupled to the expandable device 100. Morespecifically, as illustrated, the attachment components 300 a-d areconfigured as substantially helical shaped coils, where a portion of thecoil, such as one end of the coil, is secured to the expandable device,and may, for example pierce through a portion of the expandable device100. As set forth in more detail below, in other embodiments, theattachment components may be configured differently as the invention isnot limited in this respect.

Regardless of the specific type of attachment component, in thisembodiment, the attachment components 300 a-d are offset from the secondaxis 120. As mentioned above, the second axis 120 defines a maximumwidth of the expandable device 100. Thus, by offsetting the attachmentcomponents from the second axis 120, the attachment components areoffset from the maximum width of the expandable device 100.

As shown in FIG. 1A, in one embodiment, the prosthesis is substantiallyelliptical shaped, such that the maximum width of the prosthesis 200 isalso along the second axis 120. Thus, in this particular embodiment, theattachment components 300 a-d are also offset from the portion of theprosthesis 200 having a maximum width. Applicant recognized thatoffsetting the attachment components 300 a-d from the maximum width ofthe expandable device 100 and/or the maximum width of the prosthesis 200may minimize the maximum dimension of the hernia repair device when thedevice is rolled or otherwise manipulated into in its reducedconfiguration.

In one embodiment, the maximum dimension of the expandable device 100 inits reduced configuration is greater along the second axis 120 (i.e. atits location of maximum width). In the particular embodiment illustratedin FIG. 1, the maximum dimension of the prosthesis 200 in its reducedconfiguration will also be greatest along the second axis. It isrecognized that the attachment components 300 a-d may also contribute tothe maximum dimension of the hernia repair device. As illustrated, inone embodiment, the attachment components 300 a-d are spaced apart, suchthat the thickness of the attachment components 300 a-d may vary acrossthe length of the prosthesis and the expandable device. By spacing theattachment components away from the maximum width of the expandabledevice and/or prosthesis when in an expanded flat configuration, theattachment components may minimally contribute to the maximum dimensionof the hernia repair device, such that the maximum dimension of thehernia repair device in its reduced configuration is minimized.

In one embodiment, an attachment component 300 a is positioned near thesecond axis 120 along a plane 130 defined as being substantiallyperpendicular to the first axis 110 (i.e. manipulation axis). Applicantrecognized that if multiple attachment components are positioned alongplane 130, then the attachment components will stack on top of eachother when the hernia repair device is manipulated into its reducedconfiguration. Thus, the multiple attachment components along that planewill cause the maximum dimension of the device in its reducedconfiguration to be greater than if only one attachment component ispositioned along the plane 130. In one embodiment, to minimize themaximum dimension of the hernia repair device in its reducedconfiguration, no other attachment component is arranged on that sameplane 130. In this respect, as the expandable device 100 is folded,rolled, or otherwise manipulated into its reduced configuration, oneattachment component 300 a is not stacked onto another attachmentcomponent 300 b. By offsetting the attachment components 300 a-d acrossthe length of the hernia repair device, the maximum dimension of thehernia repair device may be minimized when in its reduced configuration.

In this embodiment, each attachment component 300 a-d is positionedalong a plane that is defined as being substantially perpendicular tothe first axis (i.e. manipulation axis) and no other attachmentcomponent is also arranged on that same plane. For example, asillustrated, attachment component 300 a is positioned on plane 130,attachment component 300 b is positioned on plane 132, attachmentcomponent 300 c is positioned on plane 134, and attachment component 300d is positioned on plane 136. As illustrated, because all of theseplanes are substantially perpendicular to the first axis 110 (i.e.manipulation axis), these planes are also substantially parallel to eachother.

In the particular embodiment illustrated in FIG. 1A, the length of theexpandable device 100 along the first axis 110 is greater than the widthof the expandable device 100 along the second axis 120. In certainembodiments, this may be preferred so that when the expandable device100 is manipulated into its reduced configuration for insertion into thebody, the device is furled, or otherwise manipulated, about its largerdimension so that it has a more slender reduced configuration. It shouldbe appreciated that in other embodiments, the length of the expandabledevice 100 along the first axis 110 may be substantially equal to thewidth of the expandable device 100 along the second axis 120, and in yetother embodiments, the length of the device 100 may be less than thewidth, as the invention is not so limited.

The hernia repair device illustrated in FIG. 1A is shown with theexpandable device 100 and the prosthesis 200 both having a substantiallyplanar configuration. As discussed above, and as illustrated in FIGS.1B-1D, the hernia repair device may be manipulated into a reducedconfiguration for insertion into the body. As illustrated, a device 20may be used to manipulate the hernia repair device into its reducedconfiguration. For simplification of the drawings, in FIGS. 1B-1C, onlythe prosthesis 200 is illustrated and the expandable device 100 is notshown. As mentioned above, the hernia repair device may be furled,rolled, or otherwise manipulated about the first axis 110 into itsreduced configuration. As shown in FIG. 1C, in which the prosthesis 200is partially rolled up, the first axis 110 (which may be considered themanipulation axis) aligns with the longitudinal axis of the device 20used to manipulate the hernia repair device into its reducedconfiguration. It should also be appreciated that the hernia repairdevice may be folded, crumpled, collapsed or otherwise manipulated aboutthe first axis 110 into its reduced configuration.

In one embodiment, the expandable device 100 is inflatable (eitherfilled with a gas or a liquid). As shown in FIG. 1A, an inflation tube140 may be coupled to the expandable device 100 for selectivelyinflating the device. In this particular embodiment, the inflation tubeis coupled to the center portion of the expandable device, but it shouldbe appreciated that the inflation tube may be coupled to the expandabledevice in a different location. It should be recognized that before thehernia repair device is inserted into the body that the expandabledevice 100 may be in a deflated state. The expandable device 100 may notbe inflated until after it is within the body. In one particularembodiment, the expandable device 100 is inflatable with air.

The expandable device 100 may be removably connected with the softtissue repair prosthesis 200 by one or more attachment components 300,including, but not limited to sutures, adhesives, or mechanicalfasteners including hook and loop fasteners, rivets, coils, and thelike. As discussed above, in one embodiment, the attachment components300 a-d are configured as substantially helical shaped coils that extendinto/out of the page, where a portion of the coil is secured to theexpandable device, and may, for example pierce through a portion of theexpandable device 100.

Applicant recognized that the shape and orientation of the attachmentcomponents relative to the expandable device and/or the prosthesis mayaffect the maximum dimension of the hernia repair device when in itsreduced configuration. In particular, applicant determined that byorienting the attachment component such that the maximum dimension ofthe attachment component is aligned with the first axis 110 (i.e.manipulation axis), the maximum dimension of the hernia repair device inits reduced configuration may be minimized. As mentioned above, it maybe desirable to minimize the maximum dimension of the hernia repairdevice in its reduced configuration so that a smaller incision or trocarcan be used to delivery the hernia repair device into the body. Thisconcept will be discussed in greater detail with respect to FIGS. 2-7,which disclose some of the various embodiments of attachment componentsin accordance with aspects of the present invention.

The attachment component 310 shown in FIG. 2 has a substantially linearcenter portion 312 with two curved portions 314, 316 positioned on eachside of the linear portion 312. Two additional curved portions 318, 320are positioned on each side of the curved portions 314, 316, and theyare curved in the opposite direction as the curved portions 314, 316,such that the two adjacent portions form a substantially S-shaped curve.A portion of the attachment component, such as the center portion 312may be coupled to the expandable device 100. For example, in oneembodiment, the center portion 312 may be welded, or otherwise securedto the expandable device 100. As shown in FIG. 2A, one or both of theS-shaped ends of the attachment component 310 may be used to hook orotherwise couple the prosthesis 200 to the attachment component 310 andthe expandable device 100. These curved ends of the attachment component310 may assist to retain the prosthesis 200 to the expandable device100.

The attachment component 310 has a length L which defines its maximumdimension and defines its longitudinal axis. As shown in FIG. 2A, tominimize the maximum dimension of the hernia repair device in itsreduced configuration, the attachment component 310 may be arranged onthe hernia repair device such that its longitudinal axis issubstantially parallel to the first axis 110. For simplification, inFIG. 2A, the prosthesis 200 is illustrated, but the expandable device100 is not shown. In this respect, as the hernia repair device isfurled, rolled, or otherwise manipulated about the first axis 110 intoits reduced configuration, the attachment component 310 is oriented tominimally contribute to the maximum dimension of the hernia repairdevice when the device is manipulated into its reduced configuration. Itshould be appreciated that if the attachment component 310 is made of asubstantially rigid material and is oriented such that its longitudinalaxis was, for example, substantially perpendicular to the first axis 110(i.e. substantially parallel to the second axis 120), then the maximumdimension of the hernia repair device in its reduced configuration maybe at least as big as the length L of the attachment component 310,which may be undesirably too large.

FIG. 3 illustrates another embodiment of an attachment component 330which includes two substantially linear center portion 332, 334 with twocurved portions 336, 338 positioned on each side of the linear portions332, 334. As shown, the two center portions 332, 334 may form asubstantially V-shape at the center of the attachment component 330. Aportion of the attachment component 330, such as one or both of thecenter portions 332, 334 may be coupled to the expandable device 100.One or both of the curved end portions 336, 338 of the attachmentcomponent 330 may be used to hook or otherwise couple the prosthesis 200to the attachment component 330 and the expandable device 100. Theattachment component 330 has a length L which defines its maximumdimension and defines its longitudinal axis. As discussed above withrespect to attachment component 310, the attachment component 330 may bearranged on the expandable device such that its longitudinal axis issubstantially parallel to the first axis 110 (see FIG. 2A.) In thisrespect, as the hernia repair device is furled, rolled, or otherwisemanipulated about the first axis 110 into its reduced configuration, theattachment component 330 is oriented to minimally contribute to themaximum dimension of the hernia repair device in its reducedconfiguration.

FIGS. 4-7 illustrate additional attachment components in accordance withaspects of the present invention. In particular, FIG. 4 illustrates anattachment component 340 that has a V-shaped center portion 342, with asubstantially S-shaped portion 344, 346 on each end of the attachmentcomponent 340. FIG. 5 illustrates an attachment component 350 that has asubstantially linear center portion 352, with a substantially C-shapedportion 354, 356 on each end of the attachment component 350. FIG. 6illustrates an attachment component 360 with a plurality ofsubstantially linear center portions 362, 364, 366 with a substantiallyS-shaped portion 368, 370 on each end of the attachment component 360.Finally, FIG. 7 illustrates yet another embodiment of an attachmentcomponent 380. In this particular embodiment, the attachment component380 is substantially helical shaped. As illustrated, each of theseattachment component 340, 350, 360, 380 has a length L which defines itsmaximum dimension and defines its longitudinal axis. As discussed abovewith respect to attachment components 310, 330, the attachmentcomponents 340, 350, 360, 380 may be arranged on the expandable devicesuch that its longitudinal axis is substantially parallel to the firstaxis 110 (see FIG. 2A.) In this respect, as the hernia repair device isfurled, rolled, or otherwise manipulated about the first axis 110 intoits reduced configuration, the attachment component 340, 350, 360, 380is oriented to minimally contribute to the maximum dimension of thehernia repair device in its reduced configuration.

The attachment components may be formed from a variety of types ofmaterials, as the invention is not so limited. In one embodiment, theattachment components are made from a plastic or a metal material suchas, but not limited to a shape memory metal, polyurethane, or nylon heatsealed into its specific configuration. In one embodiment the attachmentcomponents are made of a substantially rigid material such that theattachment component substantially maintains its shape andconfiguration.

In one embodiment, the attachment component is made of an elastic orspring-like material which enables the attachment component to becapable of stretching out and lengthening along its longitudinal axiswhen subjected to a tensile load. In this respect, the attachmentcomponent may be stretched or otherwise elongated to either couple ordecouple the prosthesis 200 with the attachment component. Inparticular, when the attachment component is in a stretched or otherwiseelongated position (i.e. when one or both ends of the attachmentcomponent are pulled), the prosthesis 200 may more easily slide onto oroff from the ends of the attachment component. As mentioned above, thecurved ends of the attachment component may be configured to assist inretaining the prosthesis on the attachment component. By applyingtension to the attachment component, the curved ends may straighten outwhich may make it easier to either couple or decouple the prosthesis tothe attachment component. Once the prosthesis is in its desired positionon the attachment component, the tension may be removed which may causethe curved ends of the attachment component to spring back into a morecurved or coiled state to prevent the prosthesis from undesirablydecoupling from the attachment component. When the attachment componentis in its normal non-stretched position (such as in the configurationsillustrated in FIGS. 2-7) the C-shaped, S-shaped, and/or otherwise loopor curved shaped ends of the attachment components may assist incoupling and/or retaining the prosthesis 200 with the attachmentcomponent.

Although FIGS. 2-7 illustrate various embodiments of attachmentcomponents according to aspects of the present invention, it should alsobe recognized that the invention is not limited to these specificconfigurations.

Turning now to FIGS. 8-26, various embodiments of the expandable devicewill now be discussed in greater detail. It should also be recognizedthat the expandable device 100 may be formed from a variety ofmaterials, as the invention is not limited in this respect. In oneembodiment, the expandable device is formed of polyurethane, and may,for example, be formed of nylon coated polyurethane. In one embodiment,a coating such as a thermoplastic polyurethane (TPU) coating isemployed. In an embodiment where the expandable device 100 isinflatable, the expandable device may be formed of two layers of nyloncoated polyurethane that together form a chamber for the introduction ofair.

Applicant recognized that the expandable device may be shaped andconfigured in a variety of different ways. Applicant also recognizedthat it may be desirable for the expandable device to be configured suchthat the maximum dimension of the hernia repair device is minimized inits reduced configuration. As discussed below, certain aspects of thepresent invention are directed to an expandable device configured suchthat the width of the expandable device is minimized in the region wherethe width of the prosthesis is the greatest. As mentioned above, theportions of the prosthesis and/or expandable device which have themaximum width may correspond to the portions of the hernia repair devicewhich have the maximum dimension when the device is manipulated into itsreduced configuration. Thus, offsetting the maximum width portions ofthe expandable device from the maximum width portions of the prosthesismay help to minimize the maximum dimension of the device in its reducedconfiguration. For example, as mentioned above, and as illustrated inFIG. 1A, in one embodiment, the prosthesis is substantially ellipticalshaped. In this embodiment, the width of the prosthesis is greatest inthe center, along axis 120. Thus, in embodiment of the presentinvention, the width of the center portion of the expandable device isless than the width of an end portion of the expandable device. In thisrespect, the widest portion of the expandable device is not located nearthe widest portion of the prosthesis. When the hernia repair device ismanipulated into a reduced configuration about the first axis 110, thewidest portions of the expandable device 100 are then offset from thewidest portions of the prosthesis 200. This helps to minimize themaximum dimension of the hernia repair device in its reducedconfiguration.

Although many of the below-described expandable devices are configuredfor use with a substantially elliptical-shaped prosthesis, the inventionis not limited in this respect. The invention also is directed toexpandable devices which are designed for use with a prosthesis having adifferent shape, where the widest portion of the expandable device isoffset from the widest portion of the prosthesis.

As shown in FIG. 8, in one embodiment the expandable device 400 includesan expandable first or forward portion 402 spaced apart from anexpandable second or rear portion 406 with a single intermediate portion404 positioned there between connecting the forward portion 402 to therear portion 406. In one embodiment, the single intermediate portion 404is expandable. However, it is also contemplated that the singleintermediate portion 404 may be non-expandable. As discussed above, theexpandable device 400 has a first axis 110 and the expandable device 400is configured to be furled, rolled or otherwise manipulated about itsfirst axis 110 into a reduced configuration for insertion into a body.The expandable device may also have a second axis 112 which issubstantially perpendicular to the first axis 110. In this illustrativeembodiment, the second axis 112 may define a maximum width of theprosthesis 200, and in one particular embodiment, such as when theprosthesis is elliptical shaped, the first axis may intersect the secondaxis substantially at the center of the expandable device 400.

As illustrated, the expandable forward and rear portions 402, 406 of theexpandable device 400 each include sections that extend outwardly fromthe first axis 110. These sections help to unfurl and retain theprosthesis in a planar configuration once the hernia repair device isinserted into the body. In one embodiment, the expandable forward andrear portions 402, 406 may be shaped to extend along the perimeter ofthe prosthesis. The single intermediate portion 404 of the expandabledevice is configured to align with the widest portion of the prosthesis.Applicant recognized that by strategically placing only a singleintermediate connector 404 in the portion of the expandable device thatcorresponds to the maximum width portion of the prosthesis that themaximum dimension of the hernia repair device in its manipulated reducedconfiguration can be desirably decreased.

To minimize the maximum dimension of the hernia repair device in itsreduced configuration, the maximum dimension of the single intermediateportion 404 in a reduced configuration is less than the maximumdimension of the expandable device 400 at either the expandable forwardor rear portion 402, 406 in a reduced configuration. In particular, themaximum dimension of the intermediate portion 404 in a reducedconfiguration along a plane P_(c) defined by the second axis 112 is lessthan the maximum dimension of either the forward or rear portion 402,406 in a reduced configuration defined along a plane P_(f), P_(r) thatis substantially parallel to the second axis. Such a configuration maybe desirable for use with a prosthesis as discussed above, which has awidest portion aligned with the second axis 112.

In the embodiment illustrated in FIG. 8, the single intermediate portion404 extends across approximately a center third of the expandable device400. It should be appreciated that in another embodiment, theintermediate portion 404 may extend over more or less of the expandabledevice. For example, in another embodiment (shown in FIG. 10 anddiscussed below), the intermediate portion of the expandable deviceextends across approximately a center half of the expandable device.

As also illustrated in FIG. 8, in one embodiment, the singleintermediate portion 404 extends substantially along the first axis 110about which the expandable device is configured to be furled, rolled orotherwise manipulated. And as shown in FIG. 8, in one embodiment, theintermediate portion 404 is substantially linear.

FIG. 9 illustrates another embodiment of an expandable device 410 whichincludes an expandable forward portion 412 spaced apart from anexpandable rear portion 416 with a single intermediate portion 414positioned there between connecting the forward portion 412 to the rearportion 416. In this embodiment, the single intermediate portion 414 isexpandable. As shown, both the forward and rear portions 412, 416 havehook-shaped ends that extend outwardly away from the first axis 110 andthen curve inwardly back toward the first axis 110. These hook-shapedends may be shaped to extend along the perimeter of the prosthesis.Although both the forward and rear portions 412, 416 are eachillustrated with two hook-shaped ends, it should be appreciated that inanother embodiment only one of the forward and rear portions 412, 416may include a hook-shaped end, as the invention is not so limited.Furthermore, although the forward and rear portions 412, 416 have asimilar shape and configuration, it is also recognized that the forwardportion 412 may be shaped and configured differently from the rearportion 416.

FIG. 10 illustrates yet another embodiment of an expandable device 420which includes an expandable forward portion 422 spaced apart from anexpandable rear portion 426 with a single intermediate portion 424positioned there between connecting the forward portion 422 to the rearportion 426. As shown, both the forward and rear portions 422, 426 havesubstantially C-shaped ends that extend outwardly away from the firstaxis 110 that may be shaped to extend along the perimeter of theprosthesis. Although both the forward and rear portions 422, 426 areeach illustrated with two substantially C-shaped ends, it should beappreciated that in another embodiment only one of the forward and rearportions 422, 426 may include a C-shaped end, as the invention is not solimited. In this particular embodiment, the single intermediate portion424 extends in a substantially linear direction along the first axis 110and extends across approximately a center half of the expandable device420. In this embodiment, the forward portion 422 extends acrossapproximately only one quarter of the expandable device, and similarly,the rear portion 426 also only extends across approximately one quarterof the expandable device 420.

FIG. 11 similarly illustrates yet another embodiment of an expandabledevice 430 which includes an expandable forward portion 432 spaced apartfrom an expandable rear portion 436 with a single intermediate portion434 positioned there between. In this particular embodiment, both theforward and rear portions 432, 436 include a substantially linearportion and the intermediate portion 434 is also substantially linear.As shown, the substantially linear portions of the forward and rearportions 432, 436 are angled with respect to the linear intermediateportion 434. Although both the forward and rear portions 432, 436 areeach illustrated with substantially linear ends, it should beappreciated that in another embodiment only one of the forward and rearportions 432, 436 may include a linear end, as the invention is not solimited.

The expandable device 440 illustrated in FIG. 12 also has expandableforward and rear portions 442, 446 which include substantially linearportions and a single substantially linear intermediate portion 444.

Furthermore, like the embodiment shown in FIG. 9, the expandable device450 illustrated in FIG. 13 also has expandable forward and rear portions452, 456 that are connected via a single intermediate portion 454. Theforward and rear portions 452, 456 each have hook-shaped ends thatextend outwardly away from the first axis 110 and then curve inwardlyback toward the first axis 110.

FIG. 14 illustrates yet another embodiment of an expandable device 460which is similar to the embodiment illustrated in FIG. 10 in that itincludes an expandable forward portion 462 spaced apart from anexpandable rear portion 466 with a single intermediate portion 464positioned there between with both the forward and rear portions 462,466 having substantially C-shaped ends that extend outwardly away fromthe first axis 110.

The embodiment illustrated in FIG. 15 includes an expandable device 470which includes a more angular shaped expandable forward portion 472 andexpandable rear portion 476, each made up of a plurality ofsubstantially linear segments, with a single intermediate portion 474.

FIG. 16 illustrates another embodiment of an expandable device 480 whichalso includes an expandable forward portion 482, an expandable rearportion 486 and a single intermediate portion 484 positioned therebetween connecting the forward portion 482 to the rear portion 486. Inone particular embodiment, the expandable forward portion 482,expandable rear portion 486 and single intermediate portion 484 areinflatable. The overall shape of the inflatable portion of thisexpandable device 480 is similar to the overall shape of the expandabledevice 420 illustrated in FIG. 10. In addition, the expandable device480 may also includes non-expandable portions 488, 490 which extendbetween and connect the forward and rear portions 482, 486. As mentionedabove, in an embodiment where the expandable device 100 is inflatable,the expandable device may be formed of two layers of nylon coatedpolyurethane that together form a chamber for the introduction of air.In such a configuration, the non-expandable portions 488, 490 may beformed of only one layer of material, such as one layer of nylon coatedpolyurethane. These non-expandable portions 488, 490 are non-inflatable,but may still assist in retaining the overall shape of the expandabledevice 480. Furthermore, in this embodiment, because the non-expandableportions 488, 490 are formed of only one layer of the nylon material, incomparison to the two layers of the same nylon material used to form theother portions of the expandable device 480, the maximum dimension ofthe center portion of the expandable device in a reduced configuration(which includes the single intermediate portion 484 and thenon-expandable portions 488, 490) may be less than the maximum dimensionof the expandable device 480 in a reduced configuration at either theforward or rear portion 482, 486.

FIG. 17 illustrates another embodiment of an expandable device 500 whichin some respects is similar to the expandable device 420 disclosed inFIG. 10, including an expandable forward portion 502, an expandable rearportion 506 and a single intermediate portion 504 positioned therebetween connecting the forward portion 502 to the rear portion 506.However, in the embodiment illustrated in FIG. 17, the single expandableintermediate portion 504 is offset from the first axis 110.

The embodiment of the expandable device 510 illustrated in FIG. 18 issimilar in some respects to the expandable device 500 shown in FIG. 17in that it includes an expandable forward portion 512, an expandablerear portion 516 and a single intermediate portion 514 positioned therebetween connecting the forward portion 512 to the rear portion 516, withthe intermediate portion 514 is offset from the first axis 110. However,in the embodiment illustrated in FIG. 18, the intermediate portion 514is nonlinear and is substantially W-shaped.

The embodiment of the expandable device 520 illustrated in FIG. 19 isalso similar to FIG. 18, having an expandable forward portion 522, anexpandable rear portion 526 and a single intermediate portion 524positioned there between connecting the forward portion 522 to the rearportion 526, with the intermediate portion 524 offset from the firstaxis 110. However, in the embodiment illustrated in FIG. 19, theintermediate portion 524 is substantially linear. In this particularembodiment, the forward portion 522, the rear portion 526 and theintermediate portion 524 together are substantially U-shaped.

FIG. 20 illustrates yet another embodiment of an expandable device 530that in some respects is similar to the expandable device 480 shown inFIG. 16 in that it includes an inflatable portion which includes anexpandable forward portion 532, an expandable rear portion 536 and asingle intermediate portion 534 which extends along the first axis 110.In addition, the expandable device 530 also includes non-expandableportions 538, 539 which extend between and connect the forward and rearportions 532, 536. These non-expandable portions 538, 540 arenon-inflatable, but may assist in retaining the overall shape of theexpandable device 530. Furthermore, in this particular embodiment, thesenon-expandable portions 538, 539 are formed of a thin layer of amaterial, such as a suture material, so that the maximum dimension ofthe center portion of the expandable device in a reduced configuration(which includes the single expandable intermediate portion 534 as wellas the non-expandable portions 538, 539) is less than the maximumdimension of either the forward or rear portion 532, 536 in the reducedconfiguration.

The embodiment of the expandable device 540 illustrated in FIG. 21 issimilar to the expandable device 530 illustrated in FIG. 20 except thatthe shape of the expandable forward and rear portions 542, 546 isconfigured differently. The expandable device 540 also includes a singleintermediate portion 544 which extends substantially along the firstaxis 110 of the device 540. The device 540 also includes non-expandableportions 548, 549, which may be made of suture material, extendingbetween and connect the forward and rear portions 542, 546. Thenon-expandable portions 548, 549 may be configured to retain the shapeof the expandable device when in an expanded or planar configuration.

FIG. 22 illustrates another embodiment of an expandable device 550 whichincludes an expandable forward portion 552, an expandable rear portion556 and a single intermediate portion 554. The intermediate portion 554includes a substantially linear inflatable segment connecting theforward and rear portions 552, 556 along the first axis 110 of theexpandable device 550. The device 550 also includes a substantiallylinear non-inflatable portion 558 which is offset from the first axis110. As discussed above, the non-inflatable portion 558 may be formed ofa thin layer of material, so that the maximum dimension of the centerportion of the device 550 in the reduced configuration is less than themaximum dimension of either the forward or rear portion 552, 556 in thereduced configuration. These non-inflatable portions 558 may beconfigured to hold the shape of the expandable device when in a planarconfiguration.

FIGS. 23 and 24 illustrate additional embodiments of the expandabledevice 560, 570, both of which have a substantially S-shapedconfiguration. Each device 560, 570 includes an expandable forwardportion 562, an expandable rear portion 566 and a single intermediateportion 564 extending between and connecting the forward portion 562 andthe rear portion 566. In both of these embodiments, the intermediateportion 564 extends substantially along a diagonal relative to the firstaxis 110.

FIG. 25 also illustrates an additional embodiment of the expandabledevice 580 which has a single intermediate portion 584 that extendssubstantially along a diagonal relative to the first axis 110. Theexpandable device 580 shown in FIG. 25 has an expandable forward portion582 and an expandable rear portion 586 which form approximately anN-shaped expandable device 580 with the intermediate portion 584, andthe maximum dimension of the intermediate portion 584 in the reducedconfiguration is less than the maximum dimension of either the forwardor rear portion 582, 586 in the reduced configuration.

FIG. 26 illustrates a further embodiment of an expandable device 590according to the present invention. In some respects, this expandabledevice is configured similar to the expandable device 100 shown in FIG.1A. In contrast, the expandable device 590 includes indicia 592, 594 oneach end of the expandable device 590 which indicate the superior andinferior ends of the device. Such indicia 592, 594 may assist the userin positioning the expandable device 590 and the prosthesis 200 withinthe body. In this particular embodiment, the indicia 592, 594 areconfigured as arrow head and an arrow end, but it should be appreciatedthat other types of indicia, such as numbers, letters, arrows, or othervarious markings, may be used as the invention is not so limited.

With the soft tissue repair prosthesis deployed and expanded in theintra-abdominal space, a suture-grasping device (not shown) may beprovided to grasp and hoist the prosthesis 200 towards the defect and/orto position the soft tissue repair prosthesis against the abdominalwall. Once the soft tissue repair prosthesis 200 is positioned relativeto the defect, sutures, fasteners, adhesives or the like may be appliedto fixate the prosthesis 200 in place.

After placement of the prosthesis 200, the attachment components may beleft in place or, instead, removed. As an example, and withoutlimitation, an instrument may be employed to remove the attachmentcomponents. In one embodiment, the attachment components are resorbable.

A method of repairing a hernia defect in accordance with the presentinvention includes one or more of the acts of: detachably securing anexpandable device to a prosthesis, rolling, folding or otherwisemanipulating the prosthesis and detachably secured expandable deviceinto a slender configuration, inserting the prosthesis and expandabledevice into the intra-intra-abdominal space, inflating or otherwiseexpanding the expandable device to unfurl the mesh, hoisting theprosthesis up against the abdominal wall, fixating the prosthesisagainst the abdominal wall, detaching the expandable device from theprosthesis, and removing the attachment components and the expandabledevice from the intra-intra-abdominal space.

A method of assembling a hernia repair device in accordance with thepresent invention includes one or more of the acts of: arranging a softtissue repair prosthesis on an expandable device with at least oneattachment component, where the prosthesis, expandable device andattachment component form a hernia repair device, and manipulating thehernia repair device about a first axis into a reduced configuration,where the soft tissue repair prosthesis is arranged on the expansiondevice such that a maximum dimension of the hernia repair device in thereduced configuration is minimized.

Turning back to FIG. 1A, in one embodiment, the attachment components300 a-d are positioned to extend entirely within the perimeter (i.e. theouter boundary) of the expandable device 100. In other words, portionsof the attachment components 300 a-d do not extend beyond the perimeterof the expandable device 100. Applicant recognized that when suturingthe prosthesis to the abdominal wall, the user may inadvertently passthe suture through the attachment component. Applicant furtherrecognized that it may be desirable to position the attachmentcomponents to extend entirely within the perimeter of the expandabledevice to minimize the risk of inadvertently fixing the attachmentcomponents to the prosthesis when the prosthesis is, for example, beingfastened to the abdominal wall.

Once the prosthesis 100 is positioned against the abdominal wall, it maybe difficult for a user to visually detect the location of all of theattachment components. For example, the prosthesis may be opaque andthus the user may not see portions of the attachment component thatextend behind the prosthesis. Applicant recognized that the user will beable to visually detect the location of the expandable device. Thus, theuser may be able to more easily avoid inadvertently fixing theprosthesis to the expandable device when the prosthesis is beingfastened to the abdominal wall. By placing the attachment componentsentirely within the perimeter of the expandable device 100, then whenthe user avoids the expandable device when securing the prosthesis tothe wall, the user will also then avoid securing the attachmentcomponents to the prosthesis.

As shown in FIG. 1A, in one embodiment, the expandable device 100 mayinclude both an expandable portion 150 and a non-expandable portion 152.In this particular embodiment, the non-expandable portion 152 is formedaround the perimeter of the expandable portion 150 and substantiallyfollows the shape of the expandable portion 150.

Applicant recognized that in some embodiments, it may be desirable toarrange the attachment components to extend within the non-expandableportion 152. For example, it may be desirable to arrange the attachmentcomponents within the non-expandable portion 152 in an embodiment wherethe expandable device is inflatable. By placing the attachmentcomponents, which may include a sharp end, away from the inflatableexpandable portion 150, a user may be less likely to puncture orotherwise damage the expandable device. As shown in FIG. 1A, theexpandable device may include a non-expandable portion 152 withsubstantially circular shaped portions at locations spaced around theouter portion of the expandable device configured for the placement ofthe attachment components 300 a-d.

As shown in FIGS. 8, 10, 12, 16, 18, 19 and 25, the expandable devicemay include a non-expandable portion 152 positioned on the ends of theexpandable device, and as illustrated, such non-expandable portions 152may be arranged on the first axis 110 (furling axis) to provide a tabfor the user to grasp the expandable device 100 while minimizing therisk of damaging the expandable portions.

FIGS. 27 and 28 illustrate further embodiments of an expandable device600, 620 according to aspects of the present invention. In oneembodiment, these expandable devices 600, 620 are inflatable, and asdiscussed above, these devices 600, 620 are configured to be removablyconnected with a soft tissue repair prosthesis and when deflated, areconfigured to be manipulated about a first axis 110 into a reducedconfiguration for insertion into a body.

Applicant recognized that when the expandable device is inflated andtransformed from a substantially two-dimensional configuration to athree-dimensional configuration that the device may bend, bow or twistsuch that the three-dimensional inflated configuration may not be asubstantially planar configuration. Applicant determined that thisbending may be more prominent at the perimeter of the expandable device.

In some circumstances, it may be desirable for the three-dimensionalinflated configuration to have a substantially planar configuration. Inother circumstances, it may be desirable for the three-dimensionalinflated configuration to have a substantially curved configuration, butit may be desirable for the device to only curve or bend to a certaindegree. For example, when the inflatable device is used to position aprosthesis adjacent a hernia defect in an abdominal wall, it may bedesirable for the curvature of the device to follow the contour of theabdominal wall.

Thus, Applicant developed an approach to minimize the bending of theinflatable device when inflated. In particular, as illustrated in FIGS.27 and 28, in one embodiment, the inflatable devices include a pluralityof reliefs 602, 604 spaced around the perimeter of the inflatable device600, 620 which are configured to minimize bending of the inflatabledevice when inflated. Applicant recognized that the undesirable bendingof the inflatable device may occur in regions of the device where thecross-section or diameter of the device is not constant (such as at ajoint where multiple inflatable portions intersect). Thus, as shown, thereliefs 602, 604 may be positioned in these areas where the crosssection of the device is not constant. The reliefs 602, 604 may act tominimize the variation in the cross-section or diameter of the devicesuch that the device is inflated more evenly and with less twisting.

In one illustrative embodiment, a relief 602, 604 is configured as anotch, whereas in another embodiment, a relief 602 may be configured asa slit. In the illustrative embodiment, a plurality of substantiallyV-shaped notches 602 are positioned around the perimeter of the deviceand are outwardly facing to allow the device to open outwardly as it isinflated. As shown, the device 600, 620 may also include reliefs 604that are substantially U-shaped that are positioned around the perimeterof the device and are inwardly facing to allow the device to openinwardly as it is inflated. In some respects, these reliefs 602, 604help to control where and/or to what degree the device 600, 620 bends asit is inflated.

In one embodiment, the reliefs 602, 604 are configured such that theinflatable device 600, 620 is substantially planar when inflated intoits three dimensional configuration. In another embodiment, the reliefs602, 604 are configured such that the inflatable device has asubstantially curved configuration when inflated into itsthree-dimensional configuration. The reliefs 602, 604 may be configuredto minimize the amount of bending which occurs such that a predetermineddesired curved configuration is achieved, for example, to follow thecontour of the abdominal wall.

The embodiment illustrated in FIG. 28 is similar to the one disclosed inFIG. 27, except that the inflatable device 620 in FIG. 28 includes aplurality of seams 610 which separate portions of the inflatable device.These seams 610 may assist to make inflation of the device 620 moreuniform. In one embodiment, the seams 610 may be welded. The inflatabledevice 600, 620 may be inflated with an inflation tube (not shown) thatmay connect to the device 600, 620 at an inflation port 612 positionedapproximately at the center of the device. Furthermore, the device 600,620 may include a plurality of non-expandable portions 152, and asmentioned above, it may be desirable to arrange the attachmentcomponents within the non-expandable portions 152 in an embodiment wherethe expandable device is inflatable.

The prosthesis 200 may be formed of a porous material, such as a knit,woven or non-woven fabric, or may be composed of a solid, substantiallynon-porous, or microporous material. The prosthesis may be formed of oneor more layers of the same or dissimilar material. The prosthesis may beformed with portions that are tissue infiltratable and other portionsthat are non-tissue infiltratable, providing selected areas of therepair device with different tissue ingrowth and adhesion resistantproperties. The prosthesis may be formed of permanent material,resorbable material, or a combination of permanent and resorbablematerials. It should be appreciated that the prosthesis may be formed ofany biologically compatible material, synthetic or natural, suitable forrepairing a tissue or muscle wall defect as would be apparent to one ofskill in the art. The prosthesis may be formed into a patch, plug orcombination patch and plug.

In one embodiment, the prosthesis 200 is formed from a mesh fabric, suchas a sheet of knitted polypropylene monofilament mesh fabric. The sheetmay have a thickness of approximately 0.014 inches and may be knittedfrom polypropylene monofilament having a diameter of approximately0.0042 inches. When implanted, the polypropylene mesh promotes rapidtissue or muscle ingrowth into and around the mesh structure.Alternatively, other surgical materials which are suitable for tissue ormuscle reinforcement and defect correction may be utilized includingBARD MESH (available from C.R. Bard, Inc.), SOFT TISSUE PATCH(microporous ePTFE—available from W.L. Gore & Associates, Inc.);SURGIPRO (available from US Surgical, Inc.); TRELEX (available fromMeadox Medical); PROLENE and MERSILENE (available from Ethicon, Inc.);and other mesh materials (e.g., available from Atrium MedicalCorporation). Biologic materials, including XENMATRIX, COLLAMEND, andALLOMAX (all available from C.R. Bard, Inc.) or COOK SURGISIS (availablefrom Cook Biomedical, Inc.) may also be used. Resorbable materials,including polyglactin (VICRYL—available from Ethicon, Inc.) andpolyglycolic acid (DEXON—available from US Surgical, Inc.), may besuitable for applications involving temporary correction of tissue ormuscle defects. The fabric may be formed from multifilament yarns andthat any suitable method, such as knitting, weaving, braiding, moldingand the like, may be employed to form the mesh material. It should beappreciated that when the soft tissue repair prosthesis is in the formof a sheet, it may be configured in many shapes, including, but notlimited to flat, concave, and convex, and may, for example, be in theform of a square, rectangle, circle, or ellipse.

The present invention also contemplates other systems for expandingand/or unfurling the prosthesis. Although inflatable expandable devices(either filled with a gas or a liquid) are primarily discussed above,other expandable devices that do not rely on inflation are contemplated.For example, and without limitation, also contemplated are an expandabledevice that includes telescoping portions and/or umbrella-like spokes,an expandable device including shape memory material, and an expandabledevice that resiliently expands into an enlarged configuration.

It should be appreciated that various embodiments of the presentinvention may be formed with one or more of the above-describedfeatures. The above aspects and features of the invention may beemployed in any suitable combination as the present invention is notlimited in this respect. It should also be appreciated that the drawingsillustrate various components and features which may be incorporatedinto various embodiments of the present invention. For simplification,some of the drawings may illustrate more than one optional feature orcomponent. However, the present invention is not limited to the specificembodiments disclosed in the drawings. It should be recognized that thepresent invention encompasses embodiments which may include only aportion of the components illustrated in any one drawing figure, and/ormay also encompass embodiments combining components illustrated inmultiple different drawing figures.

It should be understood that the foregoing description of variousembodiments of the invention are intended merely to be illustrativethereof and that other embodiments, modifications, and equivalents ofthe invention are within the scope of the invention recited in theclaims appended hereto.

The invention claimed is:
 1. A hernia repair device, comprising: aninflatable device configured to be removably connected with a softtissue repair prosthesis, the inflatable device having a firstinflatable segment and a second inflatable segment, the first inflatablesegment having a first closed end such that there is no fluidcommunication through the first closed end, and the second inflatablesegment extending past the first closed end and overlapping with aportion of the first inflatable segment over a region of overlap;wherein fluid communication between the first and second inflatablesegments is closed along the entire region of overlap.
 2. The herniarepair device of claim 1, wherein the second inflatable segment has asecond closed end that is spaced from the first closed end.
 3. Thehernia repair device of claim 1, wherein the inflatable device includesa seam between the first and second inflatable segments that closesfluid communication between the first and second inflatable segmentsalong the region of overlap.
 4. The hernia repair device of claim 3,wherein the seam is welded.
 5. The hernia repair device of claim 1,wherein, at the region of overlap, the first inflatable segment is at anoutermost perimeter of the inflatable device.
 6. The hernia repairdevice of claim 5, wherein a portion of the second inflatable segmentexcluding the region of overlap is at the outermost perimeter of theinflatable device.
 7. The hernia repair device of claim 1, wherein thefirst inflatable segment has a first longitudinal axis runninglengthwise through the first inflatable segment and the secondinflatable segment has a second longitudinal axis running lengthwisethrough the second inflatable segment, the first longitudinal axismaintaining a constant distance from the second longitudinal axis alongthe region of overlap.
 8. The hernia repair device of claim 1, whereinthe first inflatable segment has a length that is longer than the regionof overlap.
 9. The hernia repair device of claim 1, wherein the firstand second inflatable segments are in fluid communication with oneanother.
 10. The hernia repair device of claim 1, wherein the inflatabledevice has a first axis wherein, when deflated, the inflatable device isconfigured to be manipulated about the first axis into a reducedconfiguration for insertion into a body.
 11. The hernia repair device ofclaim 10, wherein the inflatable device has an intermediate segmentextending along the first axis and a first outer segment that bows awayfrom the intermediate segment, the first outer segment being formed bythe first and second inflatable segments.
 12. The hernia repair deviceof claim 11, wherein a first through-hole opening is defined between theintermediate segment and the first outer segment.
 13. The hernia repairdevice of claim 11, wherein the inflatable device has a second outersegment that bows away from the intermediate segment on an opposite sideof the intermediate segment relative to the first outer segment, thesecond outer segment being formed by a third inflatable segment and afourth inflatable segment, the third inflatable segment having a thirdclosed end and the fourth inflatable segment extending past the thirdclosed end and overlapping with a portion of the third inflatablesegment over a second region of overlap.
 14. The hernia repair device ofclaim 13, wherein a second through-hole opening is defined between theintermediate segment and the second outer segment.
 15. A hernia repairdevice, comprising: an inflatable device configured to be removablyconnected with a soft tissue repair prosthesis, the inflatable devicehaving a first inflatable segment and a second inflatable segment thatoverlaps with the first inflatable segment along a region of overlapdefined by a seam, the first inflatable segment being positioned on anouter side relative to the second inflatable segment closer to anoutermost perimeter of the inflatable device at the region of overlap.16. The hernia repair device of claim 15, wherein the seam closes fluidcommunication between the first and second inflatable segments along theregion of overlap.
 17. The hernia repair device of claim 16, wherein theseam is welded.
 18. A hernia repair device, comprising: an inflatabledevice configured to be removably connected with a soft tissue repairprosthesis, the inflatable device having a first inflatable segment anda second inflatable segment, the first inflatable segment having a firstclosed end such that there is no fluid communication through the firstclosed end, and the second inflatable segment extending past the firstclosed end and overlapping with a portion of the first inflatablesegment over a region of overlap; wherein, at the region of overlap, thefirst inflatable segment is at an outermost perimeter of the inflatabledevice.
 19. The hernia repair device of claim 18, wherein a portion ofthe second inflatable segment excluding the region of overlap is at theoutermost perimeter of the inflatable device.
 20. The hernia repairdevice of claim 18, wherein the first and second inflatable segments arein fluid communication with one another.